For the Consumer

As well as its needed effects, posaconazole (the active ingredient contained in Noxafil) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking posaconazole, check with your doctor immediately:

More common

Abdominal or stomach pain

black, tarry stools

bloody nose

blurred vision

body aches or pain

confusion

cough

diarrhea

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

fever or chills

fruit-like breath odor

heavy non-menstrual vaginal bleeding

increased thirst or urination

irregular heartbeats

loss of voice

muscle pain, spasms, or twitching

nausea or vomiting

numbness or tingling in the hands, feet, lips, mouth, or fingertips

painful cold sores or blisters on the lips, nose, eyes, or genitals

painful or difficult urination

pounding in the ears

slow or fast heartbeat

small red or purple spots on the skin

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

sweating

tender, swollen glands in the neck

tightness in the chest

trembling

trouble swallowing

unexplained weight loss

yellow eyes or skin

Less common

Fainting

irregular heartbeat, recurrent

Incidence not known

Anxiety

change in mental status

chest pain or discomfort

darkening of the skin

itching or skin rash

mental depression

seizures

sudden shortness of breath or troubled breathing

swelling of the eyes or eyelids

swelling of the face, fingers, feet, or lower legs

weakness

Some posaconazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common

Acid or sour stomach

back pain

belching

difficulty having a bowel movement (stool)

heartburn

muscle stiffness

pain in the joints

trouble sleeping

Less common

Bad, unusual, or unpleasant (after) taste

change in taste

For Healthcare Professionals

General

Thrombophlebitis was very common when multiple doses of the injection were administered via peripheral venous catheter, leading to administration via central venous catheter in later studies. The most common side effects reported with the IV injection were diarrhea, hypokalemia, pyrexia, and nausea.

The most common side effects reported with the delayed-release tablets were diarrhea, pyrexia, and nausea. The most common side effect leading to discontinuation of the delayed-release tablets was nausea (2%).

The most common side effects reported with the oral suspension in the prophylaxis clinical trials were fever, diarrhea, and nausea. The most common side effects leading to discontinuation of the oral suspension in these trials were associated with gastrointestinal disorders, including nausea (2%), vomiting (2%), and increased liver enzymes (2%).

The most common side effects reported with the oral suspension in the oropharyngeal candidiasis and refractory oropharyngeal candidiasis trials were fever, diarrhea, nausea, headache, vomiting, and coughing. The most common side effects leading to discontinuation of the oral suspension were respiratory impairment (1%) and pneumonia (1%) in patients with oropharyngeal candidiasis and AIDS (7%) and respiratory impairment (3%) in patients with refractory oropharyngeal candidiasis. Side effects occurred more often in patients with refractory oropharyngeal candidiasis. Serious side effects were reported in 55% of highly immunocompromised patients with advanced HIV disease. Fever (13%) and neutropenia (10%) were the serious side effects reported most often in these patients. Other serious side effects included altered drug levels (of other products), increased hepatic enzymes, nausea, rash, vomiting, bilirubinemia, and hepatocellular damage.[Ref]

Hematologic

Rare occurrences of hemolytic uremic syndrome and thrombotic thrombocytopenic purpura have been reported, generally in patients with concurrent cyclosporine or tacrolimus therapy for the prevention of transplant rejection or graft versus host disease.[Ref]

Rare occurrences of pulmonary embolus have been reported, generally in patients with concurrent cyclosporine or tacrolimus therapy for the prevention of transplant rejection or graft versus host disease.[Ref]

One patient taking posaconazole during a clinical trial developed torsades de pointes. This severely ill patient had a history of palpitations, recent cardiotoxic chemotherapy, hypokalemia, and hypomagnesemia; risk factors that may have contributed to or confounded the patient's condition.[Ref]

Clinically significant liver function test abnormalities during oropharyngeal candidiasis studies included increased AST, alkaline phosphatase, ALT, and total bilirubin. The majority of abnormal liver function tests in patients and healthy subjects were minor, transient, and did not lead to therapy discontinuation.

Changes in liver function tests from Grade 0, 1, or 2 at baseline to Grade 3 or 4 during prophylaxis studies included changes in ALT, bilirubin, AST, and alkaline phosphatase.

Total bilirubin greater than 1.5 times ULN (up to 22%), AST greater than 3 times ULN (up to 17%), alkaline phosphatase greater than 3 times ULN (up to 14%), and ALT greater than 3 times ULN (up to 11%) were reported.[Ref]

Professional resources

Related treatment guides

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